1. Proactive Quality Management System Implementing a Proactive Quality Strategy “A goal without a plan is just a wish.” Thomas A. Crane 612 Orr’s Camp Road Hendersonville, NC 28792 Phone: 828-696-9528 t_crane_nc@bellsouth.net http://www.cranesinhvl.info/ThomasCrane/ Thomas A. Crane – 2009 Proactive Quality Management System 1

2. Proactive Quality Management System First, make sure the basics are strong. • Where you start building an effective Proactive Quality Management System depends on how much you already have in place. If you are just beginning, keep in mind that you will not be able to accomplish everything at once, so you need to concentrate on the essentials. If you have been at it for a while then evaluate where you are and decide which elements of your QMS need strengthening and which elements of a Proactive QMS need to be added. Evaluate your present system for the following and establish or strengthen these elements. • Basic key elements: • Well defined quality goals and objectives, communicated to all levels of personnel, and with defined metrics that are reviewed to determine the effectiveness of the QMS. • Quality goals and objectives that are measureable and based on customer requirements, regulatory requirements and internal company requirements. • Corrective/Preventive action system that provides real root cause analysis and methods for evaluating corrective/preventive action’s effectiveness. • An effective method of auditing the QMS at all levels of the organization to determine effectiveness. • Management review of effectiveness of QMS and supporting appropriate actions needed for continuous improvement. • These basic elements are enablers for the rest of the QMS. With out these being strong, you will always struggle with the effectiveness of your QMS. Thomas A. Crane – 2009 Proactive Quality Management System 2

3. Proactive Quality Management System Next, measure yourself and your suppliers. Make sure that you have a robust Product Design Rationalization process that clearly identifies the customer’s needs and expectations. Begin CTQ flowdown of the critical few CTQs. Technology design reviews with Quality and Manufacturing are essential for successful CTQ flowdown. Measure the Cost of Quality (scrap, material inefficiency, warranty/complaints). PPM and pareto of defects will help identify the areas or processes that cause the greatest issues. This data will help drive continuous improvement. Evaluate your suppliers. Begin with requesting certifications and data for critical CTQs. Track the vendor’s PPM for received materials and measure their responsiveness to corrective action requests. Develop good working relationships with key vendors to encourage use of SPC. These basic measurements will start to identify the sources of your quality issues. Thomas A. Crane – 2009 Proactive Quality Management System 3

4. Proactive Quality Management System Use you data to identify where to start continuous improvement projects.. Measure OEE on key equipment/process and pareto the causes of availability, performance, and quality issues. Begin with one or two pieces of equipment as a learning tool and then translate to others. Use Lean value stream maps to begin evaluating non-value added steps and waste in your overall processes. Identifying where you are is essential to developing an effective plan to get where you want to be. Use Six Sigma tools, like DOE and capability studies, to establish your present equipment/process performance. Value added processes can be improved by using Six Sigma to reduce the variation in the process. Establish a change management process with at least basic project tracking. Remember that you can’t change everything at once. If you spread your resources to thin then solutions will come slowly and be less effective. Thomas A. Crane – 2009 Proactive Quality Management System 4

5. Proactive Quality Management System Continue to strengthen the basics and expand the use of good Lean/Sigma tools. Continue learning and growing in the use of Lean and Six Sigma tools. Look for opportunities to translate lessons learned and best practices. Give yourself time to get these basics rooted in the daily operation of your business. Once these are well established you can begin expanding their use, improving their effectiveness. Finally, add or improve the other elements of a proactive Quality Management System. (reference: Proactive Quality Strategy) Thomas A. Crane – 2009 Proactive Quality Management System 5